Effect of BIO-K+ on Symptoms of Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The IBS-GAI tool asks a single question regarding how recent IBS symptoms have changed since the start of the study. Subjects answer the question on a 1-7 Likert scale with 1 corresponding to "Substantially Worse" and 7 corresponding to "Substantially Improved".

IBS Symptom Severity Scale [ Time Frame: 12 Weeks ]

The IBS-SSS is a 5-question survey that asks the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. Subjects respond to each question on a 100-point visual analogue scale

IBS Quality of Life [ Time Frame: 12 Weeks ]

The IBS-QOL is a 34-item questionnaire that assesses the degree to which IBS interfered with quality of life for a subject over the past 30 days. Each item is rated on a 1 to 5 Likert scale, with higher values indicating a lower quality of life.

Abdominal Pain [ Time Frame: 12 Weeks ]

Abdominal pain severity will be measured on a 0-10 Likert scale.

Stool Consistency [ Time Frame: 12 Weeks ]

Stool consistency will be rated with the Bristol Stool Chart.

Stool frequency [ Time Frame: 12 Weeks ]

Throughout the study, subjects will record the number of defecations per day in a diary.

Concomitant medication use [ Time Frame: 12 Weeks ]

Throughout the study, subjects will record use of any concomitant medication and, if required, the need for rescue medication use each day in a diary.

Adverse Events [ Time Frame: 12 Weeks ]

Adverse events will be assessed throughout this clinical study. The main safety endpoint will be the proportion of subjects in each group that report one of more AEs at any time during the study.

The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms of IBS.

Detailed Description

Given the promising clinical results of previous trials of probiotics for IBS symptoms, the objective of this clinical trial is to evaluate the safety and effectiveness of a proprietary probiotic product, Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2® on symptoms of IBS in otherwise healthy adults.